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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18461136S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Irritation (1941)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device not available to stryker.
 
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) hospital (b)(6). The title of this report is ¿analysis of the t2 recon nail used with the antegrade locking mode¿ which was released in june 2018 and is associated with the t2 recon nailing system. Within that report, postoperative complications/ adverse events were reported, which occurred between january 2014 and november 2017. Based on the available device and patient information and a review of complaint handling database it was revealed that the events have not been reported by the hospital or by the author of the report, therefore 15 complaints were initiated retrospectively for different adverse events mentioned in the journal. This product inquiry addresses hardware irritation. One (case id 12) out of 2 cases. The pmcfr states: ¿in two cases (case12 and 26) the hardware was irritating the soft tissue and the removal of the implants was necessary to solve the problem. In the first of these two cases (case 12) the nail sticks out the tip of the greater trochanter in a femoral 32-a fractures. The nail used was 11 mm in diameter and 360 mm in length (18461136s batch code k112936) in a (b)(6) years old male ((b)(6)). The problem was solved by removal of the hardware. ¿.
 
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Brand NameRECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
melissa guattery
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7711356
MDR Text Key114756012
Report Number0009610622-2018-00381
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18461136S
Device Lot NumberK098BB7 / K112936
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/23/2018 Patient Sequence Number: 1
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